SUPPLY CHAIN ARTICLES
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“Holy T7 Polymerase, Batman!”: R&D Considerations For More Awe-Inspiring xRNA
It goes without saying we have some pretty ambitious therapeutic goals for linear mRNA and next-gen saRNA and circRNA. However, as my conversation with Koeris explored, we still have a lot of scientific and technical work/innovation ahead of us to make our RNA products “stronger” (in more ways than one).
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ARW's ATMP Manufacturing Must-Reads (2024 NEW YEAR'S RESOLUTIONS EDITION!)
Day-in and day-out, I write, read, listen to, and watch as much content as I can about CGT and RNA therapy manufacturing, in particular, and/or other ATMP industry-related topics that you should at least be aware of in the manufacturing facility. Once a month, I compile the articles and industry updates I think are most worthy of your time into an unconventional newsletter format (below) and send them out via email.
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4 Risk Mitigation Strategies For mRNA Production
Planning and procuring custom materials needed to manufacture mRNA remains a top concern. This article shares risk mitigation strategies for multi-sourcing, S&OP process, packaging size, and material expiry.
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Sourcing Plasmid DNA From CDMOs Got More Challenging — Here's Why
The demand for plasmid DNA products is intrinsically linked to unique market conditions and funding environments. Here's what's driving them.
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Therapeutic Oligonucleotides: Regulations & Quality Standards
Oligonucleotides have surfaced in the past few years as promising therapeutic agents to treat diseases such as neurodegenerative disorders, respiratory disorders, cancer, and diabetic retinopathy. This article recaps a recent USP workshop where participants from regulatory agencies, industry, and academia gathered to discuss best practices and perspectives.
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mRNA Vaccines: Key Considerations For Development & Manufacturing
As we wind down National Immunization Awareness Month, this article looks at the complexities around developing and manufacturing mRNA vaccines and how you should address those complexities. Topics include delivery, process validation, long-term effectiveness, GMP, regulatory approval, and more.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Transparent collaboration and innovation are essential to establishing an infrastructure that supports more agile business models and empowers widespread vaccine access.
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Learn how a robust understanding of the RNP’s critical process parameters and CQAs is crucial for ensuring product consistency, enhancing patient safety, and maintaining regulatory compliance.
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We aim to highlight that commercially available LNP reagent mix, GenVoy-ILM, is an accessible and easy-to-use LNP formulation that allows for rapid preclinical development of RNA vaccines.
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Costs of poor quality (COPQ) cannot be overstated. Review the statistics that prove how costly it can be to avoid resolving quality issues in your processes and supply chain.
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CRISPR technology is revolutionizing cell and gene therapies, but how do CRISPR clinical trials work? Follow this explanation of CRISPR therapies from the discovery phase to FDA approval.
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The single guide RNA (sgRNA) is one of the key components of successful CRISPR gene editing. Here we cover all the important aspects of sgRNA and Synthego’s sgRNA products.
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We report on the use of a novel lipid nanoparticle (LNP) reagent in a validated protocol to achieve successful complex gene editing in primary T cells with high efficiency while maintaining high cell viability.